| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01087-1 |
| Product Name/Description |
Nihon Kohden Defibrillator (semi-automated defibrillator)
Model numbers: TEC 5521 & TEC 5531
ARTG Number: 172594 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
When the defibrillator operates on battery and the remaining battery power is almost zero, the battery mark becomes '0', the charge battery message appears and an alarm sounds. If this occurs and the battery isn't replaced with a charged battery or the defibrillator is not connected to AC power, the mother board might become damaged and the defibrillator may not work. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software update will be implemented for the affected devices. |
| Contact Information |
02 9980 9669 - AHC Solutions |